LL01-251112 Junior CSV Validation Specialist
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Job Location:
Holly Springs, MS - USA
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Validation & Engineering Group Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.
We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position:
- Junior CSV Specialist
The Junior CSV Specialist supports the planning execution and documentation of Computer System Validation (CSV) activities in compliance with GxP regulations and company policies. The role assists in ensuring that computerized systems used in GMP-regulated environments are validated maintained in a compliant state and operate reliably to support manufacturing laboratory and quality operations.
Key Responsibilities
- Assist in preparing and executing validation deliverables including User Requirements (URS) Functional Specifications (FS) Design Specifications (DS) Risk Assessments Validation Plans and Reports.
- Support the creation and execution of IQ/OQ/PQ protocols for GMP systems (e.g. LIMS MES SCADA PLCs ERP QMS Data Historian etc.).
- Maintain validation documentation in accordance with GAMP 5 21 CFR Part 11 Annex 11 and company SOPs.
- Participate in system change control deviation management and periodic review processes.
- Collaborate with IT QA and system owners to ensure compliance throughout the system lifecycle.
- Assist in performing data integrity assessments and periodic audits of validated systems.
- Track and maintain validation status of systems and associated documentation.
- Support the implementation and qualification of new systems or upgrades under supervision of senior validation staff.
Qualifications
- Education: Bachelors degree in Engineering Computer Science Life Sciences or related technical field.
- Experience:
- 24 years of experience in Computer System Validation or related GxP compliance field.
- Familiarity with GAMP 5 21 CFR Part 11 and GMP principles preferred.
- Internship or exposure to validation in a biotech pharmaceutical or medical device setting is a plus.
- Technical Skills:
- Basic understanding of system development lifecycle (SDLC).
- Proficiency in Microsoft Office especially Word and Excel.
- Exposure to systems such as LIMS QMS or automation platforms (PLC/SCADA) desirable.
- Soft Skills:
- Strong attention to detail documentation and analytical thinking.
- Ability to follow procedures work collaboratively and meet deadlines.
- Effective written and verbal communication skills.
Required Experience:
Junior IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
